Aneurysm occlusion device

ABSTRACT

An occlusion device suitable for endovasculature treatment of an aneurysm in a blood vessel in a patient, including a substantially tubular structure having a proximal end region and a distal end region, having a first, expanded condition and a second, collapsed condition. The device has dimensions in the second, collapsed condition suitable for insertion through vasculature of the patient and through a neck of the aneurysm. The device further includes a control ring having a substantially annular body disposed on the proximal end region of the structure and at least substantially circumscribing the proximal end region to prevent radial expansion of the proximal end region and to provide an engagement feature during manipulation of the occlusion device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 14/230,426, filed on Mar. 31, 2014, the content of which isincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION 1. Field of Invention

The invention relates to implants within body vessels and moreparticularly to occlusion devices for small vascular openings such as aneck of an aneurysm.

2. Description of the Related Art

Vascular disorders and defects such as aneurysms and otherarterio-venous malformations are especially difficult to treat whenlocated near critical tissues or where ready access to a malformation isnot available. Both difficulty factors apply especially to cranialaneurysms. Due to the sensitive brain tissue surrounding cranial bloodvessels and the restricted access, it is very challenging and oftenrisky to surgically treat defects of the cranial vasculature.

In the treatment of aneurysms by endovascular implants, the goal is toexclude the internal volume of the aneurysm sac from arterial bloodpressure and flow. As long as the interior walls of the aneurysm aresubjected to blood pressure and/or flow, there is a risk of the aneurysmrupturing.

Non-surgical treatments include vascular occlusion devices such asembolic coils deployed using catheter delivery systems. In a currentlypreferred procedure to treat a cranial aneurysm, the distal end of anembolic coil delivery catheter is initially inserted into non-cranialvasculature of a patient, typically through a femoral artery in thegroin, and guided to a predetermined delivery site in a blood vesselwithin the cranium. The aneurysm sac is then filled with embolicmaterial that causes formation of a solid, thrombotic mass that protectsthe walls from blood pressure and flow. Preferably, the thrombotic masssubstantially restores the original blood vessel shape along the planeof the aneurysm's neck. The neck plane is an imaginary surface where theintima of the blood vessel would be if not for formation of theaneurysm. However, simply utilizing embolic coils is not alwayseffective at treating aneurysms as re-canalization of the aneurysmand/or coil compaction can occur over time.

A bag for use in an aneurysm sac is described by Greenhalgh in U.S. Pat.Nos. 6,346,117 and 6,391,037, and an aneurysm neck obstruction device isshown in U.S. Pat. No. 6,454,780 by Wallace. Detachable neck bridges aredisclosed by Abrams et al. in U.S. Pat. No. 6,036,720 and by Murphy etal. in U.S. Pat. No. 7,410,482 for example. Preferably, one or moreembolic coils are delivered within or through the neck bridges or otherobstruction devices to fill the sac of the aneurysm.

Yet another type of vaso-occlusive device is illustrated in U.S. Pat.No. 5,645,558 by Horton as having one or more strands of flexiblematerial which are wound to form a generally spherical or ovoidvaso-occlusive structure when relaxed after being placed in a vascularcavity such as an aneurysm or fistula. Similarly, U.S. Pat. No.5,916,235 by Guglielmi cites earlier patents describing detachable coilsand then discloses an expandable cage as a vaso-occlusive structure thatcan receive and retain one or more coils after the cage is expandedwithin an aneurysm. A self-expandable aneurysm filling device isdisclosed in US Patent Publication No. 2010/0069948 by Veznedaroglu etal.

It is therefore desirable to have a retrievable, repositionable devicethat cooperates with one or more embolic coils or other vaso-occlusivestructure to effectively occlude a neck of an aneurysm or otherarterio-venous malformation in a blood vessel.

SUMMARY OF THE INVENTION

An object of the present invention is to provide an improved occlusiondevice which substantially blocks flow into an aneurysm in a bloodvessel.

Another object of the present invention is to provide such an occlusiondevice which can be repositioned or retrieved from a sac of an aneurysm.

This invention features an occlusion device suitable for endovasculartreatment of an aneurysm in a blood vessel in a patient, including asubstantially tubular structure having a proximal end region and adistal end region, having a first, expanded condition and a second,collapsed condition. The device has dimensions in the second, collapsedcondition suitable for insertion through vasculature of the patient andthrough a neck of the aneurysm. The device further includes a controlring having a substantially annular body disposed on the proximal endregion of the structure and at least substantially circumscribing theproximal end region to prevent radial expansion of the proximal endregion and to provide an engagement feature during manipulation of theocclusion device.

In a number of embodiments, the control ring defines an inner passage,such as a channel established by an inner sleeve, through which at leastone embolic coil is insertable into the aneurysm. Preferably, at least aportion of the proximal end region of the tubular structure defines aplurality of openings having a sufficiently small size to enhanceocclusion of the aneurysm. In some embodiments, the tubular structurecooperates with at least one vaso-occlusion structure such as acollapsible cage-like device.

In certain embodiments, the occlusive device is capable of beingutilized in combination with a delivery member defining an inner lumenand having a distal end region carrying a grabber having at least twofinger elements, each finger element defining a gripping region tomechanically engage the control ring. In one embodiment, the grabber isformed of a metallic material and the gripping regions are notchesformed in the finger elements, each notch being sized to mechanicallyengage a portion of the control ring. The combination may furtherinclude a catheter having an inner lumen through which the delivery tubeis insertable and translatable relative to the catheter.

This invention may also be expressed as a method of treating an aneurysmin a blood vessel in a patient, the method including selecting anocclusion device with a structure having a substantially tubularstructure having a proximal end region and a distal end region, having afirst, expanded condition and a second, collapsed condition, and havingdimensions in the second, collapsed condition suitable for insertionthrough vasculature of the patient and through a neck of the aneurysm.The device further includes a control ring having a substantiallyannular body disposed on the proximal end region of the structure and atleast substantially circumscribing the proximal end region to preventradial expansion of the proximal end region.

In some embodiments, the method further includes mechanically engagingthe control ring with a grabber on a delivery tube to enablemanipulation of the occlusion device, drawing the occlusion device intoa catheter carrying the delivery tube to force the occlusion device intothe collapsed condition, inserting the catheter with the occlusiondevice into vasculature of the patient to reach the region of theaneurysm in the blood vessel, and positioning the occlusion devicewithin the aneurysm.

In certain embodiments, the method additionally includes delivering atleast one embolic coil through the delivery tube and through the controlring to secure the occlusion device within the aneurysm to occlude flowinto the aneurysm, and mechanically releasing the control ring andwithdrawing the catheter and the delivery tube from the patient. In yetother embodiments, the method further includes selecting the occlusivedevice to be attached to a collapsible cage-like vaso-occlusivestructure, and positioning the occlusive device within the aneurysmincludes utilizing the vaso-occlusive structure to secure the proximalend region of the tubular structure across the neck of the aneurysm.

BRIEF DESCRIPTION OF THE DRAWINGS

In what follows, preferred embodiments of the invention are explained inmore detail with reference to the drawings and photographs, in which:

FIG. 1 is a schematic side cross-sectional view of an inventiveocclusion device within a novel catheter delivery system positioned atthe neck of an aneurysm of a blood vessel;

FIG. 2 is an enlarged schematic side view of the delivery system of FIG.1 showing the occlusion device held in a collapsed condition;

FIG. 3 is a schematic side view similar to FIG. 1 showing the occlusiondevice according to the present invention expanding within the sac ofthe aneurysm while still being securely held by the delivery system;

FIG. 4 is a schematic side view similar to FIG. 3 showing an emboliccoil being advanced through the delivery system and the occlusion deviceinto the aneurysm;

FIG. 5 is a schematic side view similar to FIG. 2 with the microcatheterwithdrawn proximally to allow grasper fingers to release the controlring of the occlusion device;

FIG. 6 is a schematic side cross-sectional view similar to FIG. 4 afterthe delivery system has been withdrawn and with embolic coils securingthe occlusion device within the sac of the aneurysm;

FIG. 7 is a schematic cross-sectional view of a spherical mandrelestablishing the first, expanded condition for at least one an occlusiondevice according to the present invention;

FIGS. 8A and 8B are schematic side views of two hemi-spherical occlusiondevices according to the present invention derived from the occlusiondevice of FIG. 7;

FIG. 9 is a schematic side view of a single occlusion device after themandrel of FIG. 7 has been removed;

FIG. 10 is a schematic side view similar to FIG. 9 after a distalportion of the occlusion device has been removed to generate analternative open configuration;

FIG. 11 is a side view similar to FIG. 10 of an alternative occlusiondevice formed utilizing an elliptical, lozenge-shaped mandrel;

FIG. 12 is a view similar to FIG. 3 showing the occlusion devicecooperating with a cage-like vaso-occlusive structure within ananeurysm;

FIG. 13 is an enlarged schematic side view of an alternative deliverysystem for devices similar to those shown in FIG. 12 with an occlusiondevice and a vaso-occlusive structure held in a collapsed conditionbeing advanced into an aneurysm;

FIG. 14 is a schematic side cross-sectional view similar to FIG. 13after the delivery system has been withdrawn, and with thevaso-occlusive structure securing the occlusion device within the sac ofthe aneurysm;

FIG. 15 is a schematic side cross-sectional view of an inventiveocclusion device within a novel catheter delivery system positioned atthe neck of an aneurysm of a blood vessel and a catheter for deliveringan embolic device inserted into the aneurysm sac;

FIG. 16 is a schematic side cross-sectional view showing the occlusiondevice of FIG. 15 positioned at the neck of an aneurysm of a bloodvessel in a partially implanted condition and a catheter for deliveringan embolic device inserted into the aneurysm sac;

FIG. 17A is a schematic side view showing the occlusion device of FIG.16 expanded within the sac of the aneurysm while still being securelyheld by the delivery system and the catheter for delivering the embolicdevice jailed between the expanded occlusion device and a wall of theaneurysm;

FIG. 17B is a cross-sectional view of the expanded occlusion device andjailed catheter of FIG. 17A;

FIG. 18 is a schematic side view showing the expanded occlusion deviceof FIG. 17A and an embolic coil being advanced through the embolicdelivery catheter and the occlusion device into the aneurysm;

FIG. 19 is a schematic side view showing the expanded occlusion deviceof FIG. 18 after completion of implantation and removal of catheters;and

FIG. 20 is a schematic side view showing the release of an expandedocclusion device such as the occlusion device illustrated in FIGS.15-19.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

This invention may be accomplished by an occlusion device suitable forendovascular treatment of an aneurysm in a blood vessel in a patient,with a substantially tubular structure having a proximal end region anda distal end region, having a first, expanded condition and a second,collapsed condition. The device has dimensions in the second, collapsedcondition suitable for insertion through vasculature of the patient,utilizing a catheter such as a microcatheter, and through a neck of theaneurysm. The device further includes a control ring having asubstantially annular body disposed on the proximal end region of thestructure and at least substantially circumscribing the proximal endregion to prevent radial expansion of the proximal end region and toprovide an engagement feature during manipulation of the occlusiondevice.

The control ring is releasably engageable by a releasable feature suchas a grabber or at least one frangible member on a delivery member insome mechanical constructions or, in other constructions, by at leastone electrolytically severable element. Preferably, the control ringdefines an inner passage through which at least one embolic coil isinsertable into the aneurysm. In another construction, the occlusiondevice is held in place within the aneurysm by at least onevaso-occlusive structure such as a cage-like device.

FIG. 1 schematically illustrates the distal portion of a novel deliverysystem 10 including a microcatheter 12 and a delivery tube 14 holding atubular occlusion device 20 according to the present invention to beimplanted within sac S of aneurysm A emerging from blood vessel BV. Inone construction, the microcatheter 12 has a distal radiopaque markerband 13 and is advanced to the vicinity of neck N of aneurysm A suchthat marker band 13 is at the level of the neck N as seen underfluoroscopy.

Enlarged views of the distal portion of delivery system 10 and ofocclusion device 20 are provided in FIGS. 2 and 5. Occlusion device 20is shown in a second, collapsed condition in FIG. 2 within catheterlumen 11, with a control ring 22 held by grabber 30 of delivery tube 14.Control ring 22 is disposed about a proximal region 23 of devicestructure 25 and defines an inner passage 26 through which one or moreembolic coils are inserted, as described in more detail below. Structure25 of occlusion device 20 further includes a mesh body 24 and a distalregion 28.

After the delivery system 10 is positioned as shown in FIG. 1, thedelivery tube 14 is advanced within lumen 11 of catheter 12 to enableocclusion device 20 to expand into an approximately hemi-spherical shapewithin sac S as shown in FIG. 3. The shape of occlusion device 20 willconform to the shape of the sac S where device 20 touches the inner wallof the sac S. Grabber 30 continues to be constrained radially by lumen11 of catheter 12 and maintains its grip on control ring 22 with aplurality of gripping regions such as notches 36 and 38, FIG. 5. In oneconstruction, control ring 22 is radiopaque and is aligned underfluoroscopy relative to marker 13 on catheter 12 as shown in FIGS. 3 and4.

Once occlusion device 20 is positioned within sac S, at least oneembolic coil 40, FIG. 4, is advanced through lumen 15 of delivery tube14 as indicated by arrow 42, through passage 26 of control ring 22 asindicated by arrow 44, and is advanced, arrow 46, within aneurysm A tosubstantially fill sac S and to anchor body 24 of occlusion device 20against the interior wall of aneurysm A to block neck N as shown in FIG.6.

After a sufficient amount of embolic coil 40 has been fully deployedwithin sac S to anchor occlusion device 20 within aneurysm A, thecatheter 12 is withdrawn proximally, as indicated by arrow 51 in FIG. 5,while maintaining delivery tube 14 in place, to remove radial constrainton fingers 32 and 34 of grabber 30. Fingers 32 and 34 preferably arebiased radially outwardly and move in the direction of arrows 50 and 52,respectively, to disengage control ring 22 from notches 36 and 38 infingers 32 and 34, respectively.

In one construction, the catheter 12 is a polymeric microcatheterdefining an inner lumen 11 having an inner diameter of between 0.020inch and 0.027 inch, the delivery tube 14 has outer diameter that isslightly less than the inner diameter of the catheter lumen 11, and thegrabber 30 with occlusion device 20 in the collapsed condition shown inFIGS. 1 and 2 also have outer diameters that are substantially the sameas the inner diameter of the catheter lumen 11, which radiallyconstrains fingers 32 and 34 to engage control ring 22. The lumen 15 ofdelivery tube 14 has a diameter capable of allowing passage of aconventional embolic coil delivery system having a nominal outerdiameter of between 0.010 inch and 0.015 inch.

In some constructions, the delivery tube has at least one region ofincreased flexibility, especially near the distal end of the deliverytube, to minimize unintended microcatheter movement during translationof the delivery tube relative to the microcatheter. The at least oneflexible region is made in one construction by laser-cutting a patternof interrupted cuts into a medical-grade nitinol (NiTi) tube. In otherconstructions, a coiled metallic or polymeric cylindrical componentand/or a cylindrical section of flexible polymeric material is added tothe distal region of the delivery tube. The grabber is created in someconstructions by laser-cutting material forming the grabber to create atleast two finger elements, each preferably having a notch to enhancegripping of a control ring according to the present invention. Incertain constructions, the grabber is integral, that is, ismonolithically formed with the same material as the remainder of thedelivery tube and, in other constructions, is fixedly attached to thedistal end of the delivery tube.

In one construction, the structure 25 of occlusion device 20 is formedof metallic filaments that establish an expandable braided mesh tube.Suitable materials for the filaments include nitinol wires and otherbiocompatible metals, such as platinum, that will not remain in acollapsed condition after being ejected from a delivery tube.Preferably, at least one platinum wire is included for radiopacity. Inother constructions, the structure 25 is formed of at least onepolymeric material that does not become “set” in the collapsedcondition.

Suitable materials for control ring 22 discussed above, and for controlring 22 a and band 22 b discussed below in relation to FIGS. 7-8B,include biocompatible radiopaque materials such as platinum, tantalumand gold. Other suitable metallic materials include cobalt chromium,stainless steel, and combinations of two or more of biocompatiblemetals. Suitable polymeric materials include biocompatible biodegradableand non-biodegradable materials, as described in more detail below.

One technique for manufacturing an occlusion device according to thepresent invention is illustrated in FIG. 7. After structure 25 a isformed as a braided mesh tube, a control ring 22 a is disposed bycrimping and/or welding ring material about proximal region 23 a tolimit radial expansion at that site while defining an inner passage 26 athrough which one or more embolic coils can be inserted, as describedabove. Optionally, an inner sleeve such as a grommet (not shown) isinserted within structure 25 a and positioned under the control ring 23a to maintain an inner diameter opening of desired dimension for innerpassage 26 a.

In this technique, a spherical mandrel 60 such as a steel ball bearingis inserted through distal region 28 a to enlarge and expand thestructure 25 a in body region 24 a. A clamp-like element such as a band22 b is then crimped over distal region 62 to further shape the body 24a. In some techniques, the assembly is heated to set mesh body 24 a inthe expanded condition.

When two hemispherical occlusion devices are desired, a cut is madealong the circumference of mandrel 60, typically equidistant betweencontrol ring 22 a and band 22 b as indicated by dashed line 63, as wellas on the opposite sides of control ring 22 a and band 22 b as shown byarrows 64 and 66, respectively. This technique creates two separatedevices 20 a and 20 b, as depicted in FIGS. 8A and 8B, respectively.Distal end regions 28 a and 28 b are both open, such as illustrated fordevice 20 in FIGS. 1-6. Device 20 b also has body 24 b, proximal region23 b, and a passage 26 b formed by band 22 b which serves as a controlring according to the present invention. In other words, band 22 b isincorporated into an implantable device 20 b in one construction,instead of being a temporary clamp.

In alternative techniques, band 22 b is removed and mandrel 60, FIG. 7,is extracted to form the occlusion device 20 c, FIG. 9, with aconstricted yet un-constrained distal region 28 c, having a singlecontrol ring 22 a. In yet another technique, a cut is madenon-equatorially about structure 25 a, such as along line 70, togenerate device 20 d, FIG. 10. In yet other constructions, anon-spherical mandrel such as a lozenge-shaped mandrel, is utilized toform an elongated device 20 e, FIG. 11. In other words, the occlusiondevice according to the present invention can have many shapes such asround, elliptic, oblong, or otherwise asymmetric, and can have an openor a closed distal end. It is expected that an open distal end willtypically allow better conformance to the neck and sac of the aneurysmto be treated.

An alternative occlusion device 20 f according the present invention isillustrated in FIG. 12 cooperating with a cage-like vaso-occlusivestructure 80 formed of strands 82, 84, 86, 88, 90, 92 and 94 in thisconstruction. In some constructions, vaso-occlusive structure 80 issimilar to one of the embodiments disclosed in U.S. Pat. No. 5,645,558by Horton and, in certain other constructions, is similar to one of theembodiments disclosed in U.S. Pat. No. 5,916,235 by Guglielmi and in USPatent Publication No. 2010/0069948 by Veznedaroglu et al.

After a delivery system 10 f is positioned as desired relative toaneurysm A, an elongated delivery member 14 f is advanced within lumen11 f of catheter 12 f to enable occlusion device 20 f and vaso-occlusivestructure 80 to expand within sac S as shown in FIG. 12. In thisconstruction, a grabber 30 f continues to be constrained radially bylumen 11 f of catheter 12 f and maintains its grip on control ring 22 fwith a plurality of gripping regions. In one construction, control ring22 f is radiopaque and is aligned under fluoroscopy in a similar manneras described above relative to FIGS. 3 and 4.

Once vaso-occlusive structure 80 is fully deployed in an expandedcondition within sac S, structure 80 presses occlusion device 20 fagainst the interior wall and across the neck N of aneurysm A to secureit in place. In other words, vaso-occlusive structure 80 serves in anexpanded condition as a frame or lattice to anchor occlusion device 20 fagainst neck N, and occlusion device 20 f, held in place by structure80, serves as a cover extending at least across neck N, the coverpreferably being porous or otherwise defining sufficiently smallopenings, to enhance occlusion of aneurysm A. Preferably, occlusiondevice 20 f is secured to vaso-occlusive structure 80 by at least oneattachment point, being attached to at least one of a portion of theinterior surface of device 20 f and a portion of the control ring 22 f,to maintain an aligned relationship between the device 20 f and thestructure 80, especially during loading and delivery of structure 80 anddevice 20 f utilizing a delivery cannula.

In certain techniques, if a surgeon or other user desires tosubstantially fill the interior of sac S, at least one embolic coil isadvanced through lumen 15 f of delivery tube 14 f, through a passage incontrol ring 22 f, and then is advanced into aneurysm A. In otherconstructions, for use where insertion of one or more embolic coils isnot desired, control ring 22 f may lack a passage.

In yet other constructions, such as illustrated in FIGS. 13-14, anocclusion device 20 g has a detachment feature 98, representing aconventional detachment joint, instead of a control ring. Examples ofelectrolytically severable joints and mechanical joints are described inU.S. Pat. No. 6,454,780 by Wallace and in U.S. Pat. No. 7,410,482 byMurphy et al., for example. Similar detachable joints are described inU.S. Pat. No. 5,916,235 by Guglielmi for cage-like vaso-occlusivestructures.

After the delivery system 10 g is positioned within blood vessel BV asshown in FIG. 13, a delivery member 14 g, also referred to as a pusher14 g, is advanced within lumen 11 g of catheter 12 g to enable occlusiondevice 20 g and vaso-occlusive structure 80 g to expand within aneurysmA as shown in FIG. 14. The connection between severable element 96 anddetachment feature 98 is then severed, mechanically and/orelectrolytically.

Body 24 g is formed of a wire mesh or braid in some constructions. Inyet other constructions, the body of the occlusive device is abiocompatible film made from one or more polymeric substances. Suitablebiocompatible compositions for film material include films or matricesof cellulose, alginate, cross-linked gels, and very thin polymer filmsof materials such as urethane, polycaprolactone (PCL), poly-lactic acid(PLA) and/or poly-glycolic acid (PGA). The film need not be erodible orbioabsorbable. In some constructions, microscopic pores or otheropenings are formed in the film having average diameters which areuniform in some constructions and non-uniform in other constructions.The geometric size of the pores is substantially constant along thelength of the structure in some embodiments and, in other embodiments,varies along the length. The number of pores is substantially uniformalong the length of the structure in some embodiments and, in otherembodiments, varies along the length. Other potential materials includepolysaccharides, colloidal compounds, and some lipid products. In analternate configuration, at least the body of the occlusive device ismade of a durable, non-erodible, non-bioabsorbable material, such as asolidified urethane foam or expanded polytetrafluoroethylene (PTFE). Insome embodiments, the material defines openings at least 10 microns indiameter prior to implantation in the patient and has a thicknessranging between 10 microns to 500 microns.

FIG. 15 schematically illustrates the distal portion of a novel deliverysystem 10 h including an occlusion device delivery catheter 12 h, adelivery tube 14 h positioned within a lumen 11 h of the occlusiondevice delivery catheter 12 h holding a tubular occlusion device 20 h,and an embolic implant delivery catheter 41 h according to the presentinvention. As illustrated, the embolic implant delivery catheter 41 hcan be delivered to the aneurysm A separately from the occlusion device20 h. A distal end of the embolic implant delivery catheter 41 h can beinserted into the sac S of the aneurysm A, and the occlusion devicedelivery catheter 12 h can be positioned to implant the occlusion device20 h within sac S of aneurysm A. In one construction, the microcatheter12 h has a distal radiopaque marker band 13 h and is advanced to thevicinity of neck N of aneurysm A such that marker band 13 h is at thelevel of the neck N as seen under fluoroscopy.

After the delivery system 10 h is positioned as shown in FIG. 15, thedelivery member 14 h is advanced within lumen 11 h of catheter 12 h toenable occlusion device 20 h to expand into an approximatelyhemi-spherical shape within sac S. FIG. 16 illustrates the expansion ofa distal end region 28 h of the occlusion device 20 h as it exits theocclusion device delivery catheter 12 h. FIG. 17A illustrates thetubular body region 24 h of the occlusion device 20 h expanded to suchthat an exterior surface of the occlusion device 20 h contacts theaneurysm A and the embolic implant delivery catheter 41 h. The shape ofocclusion device 20 h will conform to the shape of the sac S wheredevice 20 h touches the inner wall of the sac S and will conform to theembolic implant delivery catheter 41 h where device 20 h touches theembolic catheter 41 h. FIG. 17B is a cross-sectional view of FIG. 17Aillustrating the conformity of the device 20 h to the inner wall of thesac S and the embolic implant delivery catheter 41 h. The body region 24h of the occlusion device 20 h is in the expanded condition provides aforce to appose the embolic catheter 41 h to the aneurysm wall.

Once occlusion device 20 h is positioned within sac S, at least oneembolic coil 40 h, FIG. 18, is advanced through a lumen of the embolicimplant delivery catheter 41 h to substantially fill sac S and to anchorbody 24 h of occlusion device 20 h against the interior wall of aneurysmA to block neck N as shown in FIG. 19. As is apparent, once the emboliccoil 40 h is delivered, the embolic implant delivery catheter 41 h canbe removed. Once removed from the sac S, the occlusion device 20 h canconform to the remaining section of the inner wall.

Referring collectively to FIGS. 15-18, during implantation of theocclusion device 20 h and the embolic coil 40 h a control ring 22 h neara proximal end region 23 h of the occlusion device 20 h can be held by agrabber 30 h on the delivery member 14 h. After a sufficient amount ofembolic coil 40 h has been fully deployed within sac S to anchorocclusion device 20 h within aneurysm A, the occlusion device 14 h canbe released from the delivery member 14 h. The grabber 30 h can beconstrained by the occlusion device delivery catheter 12 h, and fingers32 h and 34 h of the grabber 30 h can expand when exiting the occlusiondevice delivery catheter 12 h to release the control ring 22 h as shownin FIG. 20. The grabber 30 h can have a plurality of gripping regionssuch as notches 36 h and 38 h. In one construction, control ring 22 h isradiopaque and is aligned under fluoroscopy relative to marker 13 h oncatheter 12 h as shown in FIGS. 15-18 and 20. Fingers 32 h and 34preferably are biased radially outwardly to disengage control ring 22 hfrom notches 36 h and 38 h in fingers 32 h and 34 h, respectively.

An advantage of the system 10 h illustrated in FIGS. 15-20 is that theocclusion device delivery catheter 12 h, the control ring 22 h, and thedelivery member 14 h need not be sized to deliver an embolic implant.Because the delivery member 14 h need not be sized to delivery anembolic implant, numerous alternative delivery or pusher apparatus canbe used in place of or in addition to the delivery members and deliverytubes described herein.

In one construction, the tubular structure, mesh body region 24 h ofocclusion device 20 h is formed of metallic filaments that establish anexpandable braided mesh tube. Suitable materials for the filamentsinclude nitinol wires and other biocompatible metals, such as platinum,that will not remain in a collapsed condition after being ejected from adelivery tube. Preferably, at least one platinum wire is included forradiopacity. In other constructions, the tubular structure 24 h isformed of at least one polymeric material that does not become “set” inthe collapsed condition.

Thus, while there have been shown, described, and pointed outfundamental novel features of the invention as applied to a preferredembodiment thereof, it will be understood that various omissions,substitutions, and changes in the form and details of the devicesillustrated, and in their operation, may be made by those skilled in theart without departing from the spirit and scope of the invention. Forexample, it is expressly intended that all combinations of thoseelements and/or steps that perform substantially the same function, insubstantially the same way, to achieve the same results be within thescope of the invention. Substitutions of elements from one describedembodiment to another are also fully intended and contemplated. It isalso to be understood that the drawings are not necessarily drawn toscale, but that they are merely conceptual in nature. It is theintention, therefore, to be limited only as indicated by the scope ofthe claims appended hereto.

Every issued patent, pending patent application, publication, journalarticle, book or any other reference cited herein is each incorporatedby reference in their entirety.

What is claimed is:
 1. A method of treating an aneurysm in a bloodvessel in a patient, comprising: selecting an occlusion device includinga substantially tubular structure having a proximal end region and adistal end region, having a first, expanded condition and a second,collapsed condition when drawn into an occlusion device deliverycatheter, and further including a control ring having a substantiallyannular body disposed on the proximal end region of the tubularstructure and at least substantially circumscribing the proximal endregion to prevent radial expansion of the proximal end region, thetubular structure being a braided mesh tube, the tubular structurehaving a substantially hemispherical shape in the expanded condition;inserting the control ring into a notch of a finger element of a grabberdisposed at a distal end region of a delivery member to engage thecontrol ring such that the occlusion device and delivery member are inmechanical communication, the notch having an inner top surface and aninner bottom surface defining an inner cavity having a heightapproximately equal to a thickness of the control ring; drawing theocclusion device engaged with the delivery member into the occlusiondevice delivery catheter to force the occlusion device into thecollapsed condition; inserting a distal end of an embolic implantdelivery catheter into the aneurysm; inserting the occlusion devicedelivery catheter with the occlusion device into vasculature of thepatient to reach a region of the aneurysm in the blood vessel; expandingthe occlusion device to capture the embolic implant delivery catheteragainst a wall of the aneurysm; positioning the occlusion device withinthe aneurysm; and releasing the control ring at the proximal end regionfrom the notch and withdrawing the occlusion device delivery catheterfrom the patient.
 2. The method of claim 1 wherein the tubular structureincludes braided filaments.
 3. The method of claim 1 further includingdelivering at least one embolic coil through the embolic implantdelivery catheter to occlude flow into the aneurysm.
 4. The method ofclaim 3 further including providing a force by the at least one emboliccoil to secure the occlusion device within the aneurysm.
 5. The methodof claim 1 further including withdrawing the embolic implant deliverycatheter from the aneurysm.
 6. The method of claim 1 further includingutilizing the grabber to draw the occlusion device into the occlusiondevice delivery catheter carrying the delivery member to force theocclusion device into the collapsed condition.
 7. A method of treatingan aneurysm in a blood vessel in a patient, comprising: selecting anocclusion device including a substantially tubular structure having aproximal end region and a distal end region, having a first, expandedcondition and a second, collapsed condition when drawn into a deliverymicrocatheter, at least a portion of the proximal end region defining aplurality of openings having a sufficiently small size to enhanceocclusion of the aneurysm, and further including a control ring having asubstantially annular body disposed on the proximal end region of thetubular structure and at least substantially circumscribing the proximalend region to prevent radial expansion of the proximal end region, thetubular structure being a braided mesh tube, the tubular structurehaving a substantially hemispherical shape in the expanded condition;mechanically engaging the control ring with a notch on a finger elementof a grabber on a pusher member to enable manipulation of the occlusiondevice, the notch having an inner top surface and an inner bottomsurface defining an inner cavity having a height approximately equal toa thickness of the control ring; drawing the occlusion device into thedelivery microcatheter carrying the pusher member to force the occlusiondevice into the collapsed condition; inserting the deliverymicrocatheter with the occlusion device into the vasculature of thepatient to reach a region of the aneurysm in the blood vessel; insertinga distal end of an embolic implant catheter into the aneurysm;positioning the occlusion device within the aneurysm; expanding theocclusion device to capture the embolic implant catheter against a wallof the aneurysm; delivering at least one embolic coil through theembolic implant catheter to occlude flow into the aneurysm; andmechanically releasing the control ring and withdrawing the deliverymicrocatheter and the embolic implant catheter from the patient.
 8. Themethod of claim 7 further including providing a force by the emboliccoil to secure the occlusion device within the aneurysm.